VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1609240
Sex: F
Age: 60
State: MO

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: feeling like "a bad rash in mouth"; loss of taste because of chapped mouth; rash on back; rash on top of both arms; dry mouth; end (tip) of tongue burning; lips "molting like snakeskin"; inability to eat; "whole inside of mouth burning"; raw mouth; tongue "feeling sunburnt"; lips felt "sun burnt."; feeling of "rush/surge"; Chapped lips; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRY MOUTH (dry mouth), ORAL MUCOSAL ERUPTION (feeling like "a bad rash in mouth"), TONGUE DISCOMFORT (end (tip) of tongue burning), LIP EXFOLIATION (lips "molting like snakeskin") and CHAPPED LIPS (Chapped lips) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy, Allergy to chemicals (Allergic to dyes and preservatives.) and Allergy to vaccine (lip swelling). On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced CHAPPED LIPS (Chapped lips), PARAESTHESIA ORAL (tongue "feeling sunburnt"), ORAL DISCOMFORT (lips felt "sun burnt.") and FEELING ABNORMAL (feeling of "rush/surge"). On 27-Mar-2021, the patient experienced EATING DISORDER (inability to eat), ORAL DISCOMFORT ("whole inside of mouth burning") and STOMATITIS (raw mouth). On 19-Apr-2021, the patient experienced DRY MOUTH (dry mouth), TONGUE DISCOMFORT (end (tip) of tongue burning) and LIP EXFOLIATION (lips "molting like snakeskin"). On 27-Apr-2021, the patient experienced ORAL MUCOSAL ERUPTION (feeling like "a bad rash in mouth"), AGEUSIA (loss of taste because of chapped mouth), RASH (rash on back) and RASH (rash on top of both arms). At the time of the report, DRY MOUTH (dry mouth), ORAL MUCOSAL ERUPTION (feeling like "a bad rash in mouth"), TONGUE DISCOMFORT (end (tip) of tongue burning), LIP EXFOLIATION (lips "molting like snakeskin") and CHAPPED LIPS (Chapped lips) had not resolved, AGEUSIA (loss of taste because of chapped mouth), EATING DISORDER (inability to eat), ORAL DISCOMFORT ("whole inside of mouth burning"), RASH (rash on back) and RASH (rash on top of both arms) outcome was unknown, STOMATITIS (raw mouth), PARAESTHESIA ORAL (tongue "feeling sunburnt") and ORAL DISCOMFORT (lips felt "sun burnt.") was resolving and FEELING ABNORMAL (feeling of "rush/surge") had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment on visit to physician on 30-MAR-2021 includes Magic mouthwash to be used before meals, Vaseline (topical to lips), Chapstick (topical to lips), Beeswax (topical to lips). Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: updated events( rash and ageusia ), the vaccine was withdrawn after the 1st dose.

Other Meds:

Current Illness: Allergy to chemicals (Allergic to dyes and preservatives.); Food allergy

ID: 1609241
Sex: F
Age: 79
State: AZ

Vax Date: 03/22/2021
Onset Date: 03/25/2021
Rec V Date: 08/22/2021
Hospital:

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Symptom List: Anxiety, Dyspnoea

Symptoms: Muscles in the back of my legs and thighs have been giving her issues; Pain from when trying to move her legs and walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (Muscles in the back of my legs and thighs have been giving her issues) and PAIN IN EXTREMITY (Pain from when trying to move her legs and walk) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A22A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced MUSCLE DISCOMFORT (Muscles in the back of my legs and thighs have been giving her issues) and PAIN IN EXTREMITY (Pain from when trying to move her legs and walk). At the time of the report, MUSCLE DISCOMFORT (Muscles in the back of my legs and thighs have been giving her issues) and PAIN IN EXTREMITY (Pain from when trying to move her legs and walk) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided The patients treatment products information included Tylenol.

Other Meds:

Current Illness:

ID: 1609242
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
Hospital:

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Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: ear problems of tinnitus after getting the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ear problems of tinnitus after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ear problems of tinnitus after getting the vaccine). At the time of the report, TINNITUS (ear problems of tinnitus after getting the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. no concomitant product was reported. no treatment product was reported.

Other Meds:

Current Illness:

ID: 1609243
Sex: F
Age: 64
State: ME

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 08/22/2021
Hospital:

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Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: little more phantom pain than normal; This spontaneous case was reported by a consumer and describes the occurrence of PHANTOM LIMB SYNDROME (little more phantom pain than normal) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The patient's past medical history included Amputation in 2010. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced PHANTOM LIMB SYNDROME (little more phantom pain than normal). At the time of the report, PHANTOM LIMB SYNDROME (little more phantom pain than normal) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness:

ID: 1609244
Sex: M
Age:
State: NJ

Vax Date: 02/27/2021
Onset Date: 03/29/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: joint pain - felt like an increase in the arthritis pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain - felt like an increase in the arthritis pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 012A21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (joint pain - felt like an increase in the arthritis pain). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint pain - felt like an increase in the arthritis pain) outcome was unknown. No concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-080095 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-080095:Wife case

Other Meds:

Current Illness: Arthritis

ID: 1609245
Sex: F
Age: 69
State:

Vax Date: 07/01/2020
Onset Date: 12/30/2020
Rec V Date: 08/22/2021
Hospital:

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Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Fatigue; injection site pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain), HEADACHE (headache) and FATIGUE (Fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) injection for Crohn's disease and Rheumatoid arthritis and METHOTREXATE for Psoriasis. The patient's past medical history included Cyst ovary from April 2020 to September 2020, Appendicitis in January 2015, Hepatic steatosis, General physical condition abnormal in 2012, Weight increased in 2012 and Elevated liver enzymes in 2017. Previously administered products included for an unreported indication: HUMIRA (40 mg/0.4 ml - for MODERATE TO SEVERE ADULT CROHN'S DISEASE and MODERATE TO SEVERE RHEUMATOID ARTHRITIS) in 2010 and LIDOCAINE from September 2020 to October 2020. Concurrent medical conditions included Drug allergy (Sulfa drug allergy associated with manifestations of itching and burning skin.), Diabetes mellitus since 2016, Psoriasis since 2016, Shingles in November 2020, Rheumatoid arthritis (Moderate to severe) and Crohn's disease (Moderate to severe). Concomitant products included DOXYCYCLINE and LIDOCAINE for an unknown indication. In July 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started METHOTREXATE (unknown route) at an unspecified dose. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (injection site pain) and HEADACHE (headache). On an unknown date, the patient experienced FATIGUE (Fatigue). On 03-Jan-2021, VACCINATION SITE PAIN (injection site pain) and HEADACHE (headache) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. This case was linked to MOD-2021-080937 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 has no significant updates

Other Meds: DOXYCYCLINE; LIDOCAINE

Current Illness: Diabetes mellitus; Drug allergy (Sulfa drug allergy associated with manifestations of itching and burning skin.); Psoriasis; Rheumatoid arthritis (Moderate to severe)

ID: 1609246
Sex: M
Age:
State: CA

Vax Date: 04/18/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

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Symptom List: Pyrexia, White blood cell count decreased

Symptoms: was cold in the morning; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (was cold in the morning), PAIN (body ache) and PYREXIA (fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (was cold in the morning), PAIN (body ache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING COLD (was cold in the morning), PAIN (body ache) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1609247
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
Hospital:

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Symptom List: Pharyngeal swelling

Symptoms: This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSFUSION (got a blood transfusion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSFUSION (got a blood transfusion). At the time of the report, TRANSFUSION (got a blood transfusion) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1609248
Sex: M
Age: 56
State: PA

Vax Date: 04/10/2021
Onset Date: 04/19/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: 3 inches around the injection site is red, warm and hard; 3 inches around the injection site is red, warm and hard; 3 inches around the injection site is red, warm and hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (3 inches around the injection site is red, warm and hard), VACCINATION SITE WARMTH (3 inches around the injection site is red, warm and hard) and VACCINATION SITE INDURATION (3 inches around the injection site is red, warm and hard) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (3 inches around the injection site is red, warm and hard), VACCINATION SITE WARMTH (3 inches around the injection site is red, warm and hard) and VACCINATION SITE INDURATION (3 inches around the injection site is red, warm and hard). At the time of the report, VACCINATION SITE ERYTHEMA (3 inches around the injection site is red, warm and hard), VACCINATION SITE WARMTH (3 inches around the injection site is red, warm and hard) and VACCINATION SITE INDURATION (3 inches around the injection site is red, warm and hard) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. treatment products included Advil

Other Meds: ROSUVASTATIN

Current Illness: Cholesterol

ID: 1609249
Sex: F
Age:
State: AL

Vax Date: 03/18/2021
Onset Date: 04/15/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Arm is swollen; Arm is hot; Arm is red; have a terrible pain; muscle pain in her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Arm is hot), VACCINATION SITE DISCOLOURATION (Arm is red), PAIN IN EXTREMITY (have a terrible pain) and MYALGIA (muscle pain in her shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 045AUA) for COVID-19 vaccination. Concomitant products included GLICLAZIDE (MICROZIDE [GLICLAZIDE]), LOSARTAN POTASSIUM (COZAAR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VORTIOXETINE HYDROBROMIDE (TRINTELLIX), Colanapin and ALLOPURINOL (ELAVIL [ALLOPURINOL]) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Arm is hot), VACCINATION SITE DISCOLOURATION (Arm is red), PAIN IN EXTREMITY (have a terrible pain) and MYALGIA (muscle pain in her shoulder). At the time of the report, PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Arm is hot), VACCINATION SITE DISCOLOURATION (Arm is red), PAIN IN EXTREMITY (have a terrible pain) and MYALGIA (muscle pain in her shoulder) outcome was unknown. Not Provided Treatment details included Tylenol Extra strength.

Other Meds: MICROZIDE [GLICLAZIDE]; COZAAR; PROTONIX [OMEPRAZOLE]; TRINTELLIX; Colanapin; ELAVIL [ALLOPURINOL]

Current Illness:

ID: 1609250
Sex: F
Age: 66
State: CT

Vax Date: 02/26/2021
Onset Date: 03/27/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: then I feel warmth in my ear; condition aggravated; Persistent side effect of Nausea; Migraine; Frontal headache; Ringing in ears more on left ear/pattern feel is some ringing on ear; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Ringing in ears more on left ear/pattern feel is some ringing on ear), FEELING HOT (then I feel warmth in my ear), MIGRAINE (Migraine), CONDITION AGGRAVATED (condition aggravated) and HEADACHE (Frontal headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Open angle glaucoma since 04-Aug-2018, Penicillin allergy, Sulfonamide allergy (sulfa allergy) and Drug allergy (Erythromycin allergy). Concomitant products included LATANOPROST (XALATAN) from 04-Aug-2018 to an unknown date for Open angle glaucoma. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced TINNITUS (Ringing in ears more on left ear/pattern feel is some ringing on ear). 27-Mar-2021, the patient experienced HEADACHE (Frontal headache). On 14-Jul-2021, the patient experienced MIGRAINE (Migraine). On an unknown date, the patient experienced FEELING HOT (then I feel warmth in my ear), CONDITION AGGRAVATED (condition aggravated) and NAUSEA (Persistent side effect of Nausea). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) at a dose of UNK, bid; METHYLPREDNISOLONE from 20-Apr-2021 to 23-Apr-2021 for Frontal headache, at a dose of 4 milligram; NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLIN) on 04-May-2021 for Tinnitus, at a dose of 25 milligram and VENLAFAXINE HCL on 14-Mar-2021 at a dose of 37.5 milligram once. At the time of the report, TINNITUS (Ringing in ears more on left ear/pattern feel is some ringing on ear), MIGRAINE (Migraine) and HEADACHE (Frontal headache) had not resolved and FEELING HOT (then I feel warmth in my ear), CONDITION AGGRAVATED (condition aggravated) and NAUSEA (Persistent side effect of Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Acoustic stimulation tests: normal (normal) No auditory cause for tinnitus. ENT specialist suggested seeking help from headache clinic.. On 12-Mar-2021, Computerised tomogram: negative (Negative) CT scan done at radiology office. On 14-Apr-2021, Fibrin D dimer: negative (Negative) negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 : Patient demographics like body weight, race, ethnicity, lab tests, Medical history were added , concomitant medication and treatment medication were added,New event Migraine was added. On 14-Jul-2021: Follow up received on 14-JUL-2021:event Migraine outcome was updated to Not recovered.

Other Meds: XALATAN

Current Illness: Drug allergy (Erythromycin allergy); Open angle glaucoma; Penicillin allergy; Sulfonamide allergy (sulfa allergy)

ID: 1609251
Sex: M
Age: 52
State: IN

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: cramping pain; I would describe it as a nickel size circle area with flashing pain in my left shin; flashing pain like arthritis pain mostly in left leg but in right leg too; a couple days of a really bad stomach ache. I was laying in bed with extreme pain in my stomach, cramping pain; I have been having very severe headaches; pain and swelling in arm; swelling in arm; severe bruising on arm after receiving the vaccination. With each passing day, it is getting darker and spreading to shoulder. It is dark, black bruising.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain and swelling in arm), PERIPHERAL SWELLING (swelling in arm), VACCINATION SITE BRUISING (severe bruising on arm after receiving the vaccination. With each passing day, it is getting darker and spreading to shoulder. It is dark, black bruising.), ABDOMINAL PAIN UPPER (a couple days of a really bad stomach ache. I was laying in bed with extreme pain in my stomach, cramping pain) and ABDOMINAL PAIN (cramping pain) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain and swelling in arm), PERIPHERAL SWELLING (swelling in arm), VACCINATION SITE BRUISING (severe bruising on arm after receiving the vaccination. With each passing day, it is getting darker and spreading to shoulder. It is dark, black bruising.) and HEADACHE (I have been having very severe headaches). On 13-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (a couple days of a really bad stomach ache. I was laying in bed with extreme pain in my stomach, cramping pain). On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (flashing pain like arthritis pain mostly in left leg but in right leg too). On an unknown date, the patient experienced ABDOMINAL PAIN (cramping pain) and MEDIAL TIBIAL STRESS SYNDROME (I would describe it as a nickel size circle area with flashing pain in my left shin). On 15-Apr-2021, ABDOMINAL PAIN UPPER (a couple days of a really bad stomach ache. I was laying in bed with extreme pain in my stomach, cramping pain) had resolved. At the time of the report, PAIN IN EXTREMITY (pain and swelling in arm), PERIPHERAL SWELLING (swelling in arm), VACCINATION SITE BRUISING (severe bruising on arm after receiving the vaccination. With each passing day, it is getting darker and spreading to shoulder. It is dark, black bruising.), ABDOMINAL PAIN (cramping pain), PAIN IN EXTREMITY (flashing pain like arthritis pain mostly in left leg but in right leg too), MEDIAL TIBIAL STRESS SYNDROME (I would describe it as a nickel size circle area with flashing pain in my left shin) and HEADACHE (I have been having very severe headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1609252
Sex: F
Age: 59
State: MA

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Felt throat swelling and tightness of chest; Felt throat swelling and tightness of chest; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Felt throat swelling and tightness of chest) and CHEST DISCOMFORT (Felt throat swelling and tightness of chest) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Felt throat swelling and tightness of chest). 24-Mar-2021, the patient experienced CHEST DISCOMFORT (Felt throat swelling and tightness of chest). On 24-Mar-2021, PHARYNGEAL SWELLING (Felt throat swelling and tightness of chest) and CHEST DISCOMFORT (Felt throat swelling and tightness of chest) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1609253
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Received an improperly stored dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Received an improperly stored dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received an improperly stored dose). At the time of the report, PRODUCT STORAGE ERROR (Received an improperly stored dose) had resolved. The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported

Other Meds:

Current Illness:

ID: 1609254
Sex: M
Age: 64
State: NJ

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: fatigue; elevated temperature; diarrhea; soreness in left arm; rash to left arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in left arm), RASH (rash to left arm), FATIGUE (fatigue) and PYREXIA (elevated temperature) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in left arm), RASH (rash to left arm) and PYREXIA (elevated temperature). On 17-Apr-2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. On 17-Apr-2021, FATIGUE (fatigue) had resolved. At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in left arm), RASH (rash to left arm) and PYREXIA (elevated temperature) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1609255
Sex: M
Age: 69
State: IN

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Right ankle started to swell,Still swelling, getting bigger, bigger as size of grape fruit; Joint pain in right clavicle; arm was sore at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of OEDEMA PERIPHERAL (Right ankle started to swell,Still swelling, getting bigger, bigger as size of grape fruit), ARTHRALGIA (Joint pain in right clavicle) and INJECTION SITE PAIN (arm was sore at injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The patient's past medical history included Psoriasis and Hepatitis C. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INJECTION SITE PAIN (arm was sore at injection site). On 18-Apr-2021, the patient experienced ARTHRALGIA (Joint pain in right clavicle). On 19-Apr-2021, the patient experienced OEDEMA PERIPHERAL (Right ankle started to swell,Still swelling, getting bigger, bigger as size of grape fruit). At the time of the report, OEDEMA PERIPHERAL (Right ankle started to swell,Still swelling, getting bigger, bigger as size of grape fruit), ARTHRALGIA (Joint pain in right clavicle) and INJECTION SITE PAIN (arm was sore at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no treatment medication and concomitant medication provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: significant follow up-contact information updated

Other Meds:

Current Illness:

ID: 1609256
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown This case is crosslinked with MOD21-078568

Other Meds:

Current Illness:

ID: 1609257
Sex: M
Age: 53
State: GA

Vax Date: 03/19/2021
Onset Date: 04/17/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Body rash that is coming and going; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Body rash that is coming and going) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Body rash that is coming and going). At the time of the report, RASH (Body rash that is coming and going) outcome was unknown. Not Provided No concomitant medications reported. No treatment information reported.

Other Meds:

Current Illness:

ID: 1609258
Sex: M
Age:
State:

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medical provided by the reporter. Treatment includes: paracetamol. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1609259
Sex: F
Age: 59
State: NJ

Vax Date: 03/12/2021
Onset Date: 04/14/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: confusion; short term memory loss; Shortness of breath; tingling of hands and feet; Knee sensitive to light; Body ache; Rash on cheeks and forehead; Joint pain in left hand, and thumb, knees, ankles, hips, shoulders, lower back; Extreme fatigue; Intermittent headache; all of the side effects from the first symptoms with the second shot aside from the nausea and; has been sleeping 12-14 hours since the second shot; her right hand and left ankle is swollen; tongue is swollen; cannot get up; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (all of the side effects from the first symptoms with the second shot aside from the nausea and), HYPERSOMNIA (has been sleeping 12-14 hours since the second shot), PERIPHERAL SWELLING (her right hand and left ankle is swollen), SWOLLEN TONGUE (tongue is swollen) and MOVEMENT DISORDER (cannot get up) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LOSARTAN from 01-Jan-2010 to an unknown date, ESTRADIOL (DIVIGEL) from 01-Jan-2010 to an unknown date and ATORVASTATIN from 01-Jan-2010 to an unknown date for an unknown indication. On 12-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced SYMPTOM RECURRENCE (all of the side effects from the first symptoms with the second shot aside from the nausea and), HYPERSOMNIA (has been sleeping 12-14 hours since the second shot), PERIPHERAL SWELLING (her right hand and left ankle is swollen), SWOLLEN TONGUE (tongue is swollen) and MOVEMENT DISORDER (cannot get up). On an unknown date, the patient experienced CONFUSIONAL STATE (confusion), AMNESIA (short term memory loss), DYSPNOEA (Shortness of breath), PARAESTHESIA (tingling of hands and feet), KNEE DEFORMITY (Knee sensitive to light), PAIN (Body ache), RASH (Rash on cheeks and forehead), ARTHRALGIA (Joint pain in left hand, and thumb, knees, ankles, hips, shoulders, lower back), FATIGUE (Extreme fatigue) and HEADACHE (Intermittent headache). At the time of the report, SYMPTOM RECURRENCE (all of the side effects from the first symptoms with the second shot aside from the nausea and), HYPERSOMNIA (has been sleeping 12-14 hours since the second shot), PERIPHERAL SWELLING (her right hand and left ankle is swollen), SWOLLEN TONGUE (tongue is swollen), MOVEMENT DISORDER (cannot get up), CONFUSIONAL STATE (confusion), AMNESIA (short term memory loss), DYSPNOEA (Shortness of breath), KNEE DEFORMITY (Knee sensitive to light), PAIN (Body ache), RASH (Rash on cheeks and forehead), ARTHRALGIA (Joint pain in left hand, and thumb, knees, ankles, hips, shoulders, lower back), FATIGUE (Extreme fatigue) and HEADACHE (Intermittent headache) outcome was unknown and PARAESTHESIA (tingling of hands and feet) had not resolved. Not Provided Patient mentioned insomnia due to body and muscle ache. Treatment for the events was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-080450 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Concomitant medications, new events, race, ethnicity, height, weight were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded US-MODERNATX, INC.-MOD-2021-080450:1st dose case

Other Meds: LOSARTAN; DIVIGEL; ATORVASTATIN

Current Illness:

ID: 1609260
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/17/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, HEADACHE and FATIGUE in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 17-Apr-2021, the patient experienced ASTHENIA, HEADACHE and FATIGUE. The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ASTHENIA, HEADACHE and FATIGUE outcome was unknown. Patient declares that she is not taking medication. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1609261
Sex: F
Age: 46
State: NV

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Felt like throat was going to swell), MALAISE (Felt sick), DYSPHONIA (Throat was a little hoarse), INJECTION SITE PAIN (Injection site pain) and VOMITING (Throwing up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0s7b21a) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DYSPHONIA (Throat was a little hoarse). On 17-Apr-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 18-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Felt like throat was going to swell), MALAISE (Felt sick) and VOMITING (Throwing up). On 18-Apr-2021, VOMITING (Throwing up) had resolved. At the time of the report, PHARYNGEAL SWELLING (Felt like throat was going to swell), MALAISE (Felt sick), DYSPHONIA (Throat was a little hoarse) and INJECTION SITE PAIN (Injection site pain) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient experienced a swollen throat after having 3 drinks in a 6 hour period. Her throat was a little hoarse on 16-Apr-2021, and patient almost went to emergency room (felt like throat was going to swell shut). The patient also experienced injection site pain which lasted 3 days. On 19-Apr-2021, the patient felt a lot better. The patient took ibuprofen and allegra treat the symptoms caused by covid vaccine. The concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1609262
Sex: F
Age: 36
State: MD

Vax Date: 03/15/2021
Onset Date: 04/12/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose; body aches; headache; lethargic; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PRODUCT STORAGE ERROR (needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose), MYALGIA (body aches) and HEADACHE (headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced LETHARGY (lethargic), MYALGIA (body aches) and HEADACHE (headache). On 19-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose). On 19-Apr-2021, PRODUCT STORAGE ERROR (needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose) had resolved. At the time of the report, LETHARGY (lethargic), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown. No treatment information was provided. No relevant concomitant medications reported.

Other Meds:

Current Illness:

ID: 1609263
Sex: F
Age: 66
State: MI

Vax Date: 02/13/2021
Onset Date: 03/01/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Night sweats primarily under the lymph nodes of the right arm/woke up soaking wet four times during the night; Tenderness which is sometimes felt, sometime not felt , in the lymph nodes; Pain during the injection of the second dose; Body odor sweat, body odor being secreted from that one right arm; woke up soaking wet four times during the night/not sleeping; Pronounced aortic pulse; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats primarily under the lymph nodes of the right arm/woke up soaking wet four times during the night), SKIN ODOUR ABNORMAL (Body odor sweat, body odor being secreted from that one right arm), SLEEP DEFICIT (woke up soaking wet four times during the night/not sleeping), PULSE ABNORMAL (Pronounced aortic pulse) and LYMPH NODE PAIN (Tenderness which is sometimes felt, sometime not felt , in the lymph nodes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006H20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hot flashes and Pulse abnormalities (aortic pulse- few times over past years). Concurrent medical conditions included Fibromyalgia since 1991, Vulvodynia (vulvodynia, pelvic) since 2019, Pelvic floor dysfunction and Drug allergy (Seldane (terfenadine)). Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) from an unknown date to 12-Apr-2021 for Pain, GABAPENTIN from an unknown date to 18-Apr-2021 for Pelvic pain, VITAMIN B12 NOS, VITAMIN D3, MAGNESIUM, MELATONIN and PARACETAMOL (TYLENOL) for an unknown indication. On 13-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain during the injection of the second dose). On 14-Mar-2021, the patient experienced NIGHT SWEATS (Night sweats primarily under the lymph nodes of the right arm/woke up soaking wet four times during the night) and LYMPH NODE PAIN (Tenderness which is sometimes felt, sometime not felt , in the lymph nodes). In March 2021, the patient experienced SKIN ODOUR ABNORMAL (Body odor sweat, body odor being secreted from that one right arm), SLEEP DEFICIT (woke up soaking wet four times during the night/not sleeping) and PULSE ABNORMAL (Pronounced aortic pulse). On 13-Mar-2021, VACCINATION SITE PAIN (Pain during the injection of the second dose) had resolved. At the time of the report, NIGHT SWEATS (Night sweats primarily under the lymph nodes of the right arm/woke up soaking wet four times during the night), PULSE ABNORMAL (Pronounced aortic pulse) and LYMPH NODE PAIN (Tenderness which is sometimes felt, sometime not felt , in the lymph nodes) had not resolved and SKIN ODOUR ABNORMAL (Body odor sweat, body odor being secreted from that one right arm) and SLEEP DEFICIT (woke up soaking wet four times during the night/not sleeping) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: negative (Negative) Extensive blood work with negative results. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient had prolotherapy, a new therapy for a pre-existing condition. The patient took a Benadryl prior to the second dose's injection as per the advice of her HCP. The symptoms are still ongoing more than two months after receiving the second dose of mRNA-1273. This case was linked to MOD-2021-022772 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Patient demographic details were updated, relevant medical history was added, concomitant product details were updated, event outcomes for night sweats, lymph node pain and pronounced aortic pulse was updated from unknown to not recovered/ not resolved.; Sender's Comments: MOD-2021-022772:First Dose

Other Meds: GABAPENTIN; VITAMIN B12 NOS; VITAMIN D3; MAGNESIUM; MELATONIN; ADVIL [IBUPROFEN]; TYLENOL

Current Illness: Drug allergy (Seldane (terfenadine)); Fibromyalgia; Pelvic floor dysfunction; Vulvodynia (vulvodynia, pelvic)

ID: 1609264
Sex: F
Age: 84
State: PA

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: huge hematoma moved down in to the wrist; huge lump at patient's injection arm; arm was painful; arm became black in color; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMATOMA (huge hematoma moved down in to the wrist), VACCINATION SITE MASS (huge lump at patient's injection arm), PAIN IN EXTREMITY (arm was painful) and SKIN DISCOLORATION (arm became black in color) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure inadequately controlled. Concomitant products included METOPROLOL and LISINOPRIL for Blood pressure inadequately controlled, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BABY ASPIRIN), IRON, LEVOTHYROXINE, VITAMIN D3, FUROSEMIDE (LASIX [FUROSEMIDE]) and NAPROXEN for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE HAEMATOMA (huge hematoma moved down in to the wrist), VACCINATION SITE MASS (huge lump at patient's injection arm), PAIN IN EXTREMITY (arm was painful) and SKIN DISCOLORATION (arm became black in color). At the time of the report, VACCINATION SITE HAEMATOMA (huge hematoma moved down in to the wrist), VACCINATION SITE MASS (huge lump at patient's injection arm), PAIN IN EXTREMITY (arm was painful) and SKIN DISCOLORATION (arm became black in color) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the events included application of a cold compress over the hematoma. The patient contacted her physician on 05-Apr-2021 who advised the patient to apply cold compress over the hematoma.

Other Meds: ELIQUIS; BABY ASPIRIN; METOPROLOL; LISINOPRIL; IRON; LEVOTHYROXINE; VITAMIN D3; LASIX [FUROSEMIDE]; NAPROXEN

Current Illness: Blood pressure inadequately controlled

ID: 1609265
Sex: F
Age: 35
State: CA

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Caller is pregnant and received the 1st dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Caller is pregnant and received the 1st dose of the Moderna vaccine) in a 35-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 017c21a) for COVID-19 vaccination. The patient's past medical history included Alcohol use (3 drinks/week) from 01-Jan-2004 to 06-Apr-2021. On 17-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Mar-2021 and the estimated date of delivery was 13-Dec-2021. On 17-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Caller is pregnant and received the 1st dose of the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fifth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Caller is pregnant and received the 1st dose of the Moderna vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Prenatal screening test: low risk (Inconclusive) LOW RISK and normal (Inconclusive) NORMAL. On 04-Jun-2021, Ultrasound foetal: normal (Inconclusive) NORMAL. Patient had Prenatal Vitamin (Oral) 1/day from 01-APR-2020 (Still taking) as concomitant medication. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was Not Applicable Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Added Lab information ,updated ethnic group, race and pregnancy information

Other Meds:

Current Illness:

ID: 1609266
Sex: M
Age:
State: FL

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

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Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concomitant products included METFORMIN, LEVOTHYROXINE, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-080504 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-080504:Dose 2

Other Meds: METFORMIN; LEVOTHYROXINE; LOSARTAN; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1609267
Sex: F
Age:
State:

Vax Date: 03/03/2021
Onset Date: 04/06/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: temperature of 102; elevated blood pressure; stomach burning; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure), DYSPEPSIA (stomach burning), MYALGIA (muscle aches), FATIGUE (fatigue) and PYREXIA (temperature of 102) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer. Concurrent medical conditions included Hypertension and Endometrial cancer. Concomitant products included LISINOPRIL from 07-Apr-2021 to an unknown date for Hypertension. On 03-Mar-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 20 milligram once a day. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure), DYSPEPSIA (stomach burning), MYALGIA (muscle aches) and FATIGUE (fatigue). On 12-Apr-2021, the patient experienced PYREXIA (temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (temperature of 102) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure) had resolved and DYSPEPSIA (stomach burning), MYALGIA (muscle aches) and FATIGUE (fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 120/89 (abnormal) 120/89. On 12-Apr-2021, Body temperature: 102 (High) 102. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: LISINOPRIL; LENVIMA

Current Illness: Endometrial cancer; Hypertension

ID: 1609268
Sex: F
Age: 68
State: CA

Vax Date: 02/10/2021
Onset Date: 02/14/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: BP 136/78 in the morning; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (BP 136/78 in the morning) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 15M20A and 040A219) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HYPERTENSION (BP 136/78 in the morning). The patient was treated with AMLODIPINE for Hypertension, at a dose of 7.5 mg and BENAZEPRIL for Blood pressure high, at a dose of 20 mg. At the time of the report, HYPERTENSION (BP 136/78 in the morning) was resolving. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood pressure measurement: 136/78 (High) Increased. On 16-Mar-2021, Blood pressure measurement: 144/? (Inconclusive) Inconclusive. On 18-Apr-2021, Blood pressure measurement: 145/85 (High) increased. On 19-Apr-2021, Blood pressure measurement: 123/77 Inconclusive and 128/69 Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported that she was previously on 5mg strength amlodipine in first follow up. This case was linked to MOD-2021-080512 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up (TCR) received on 18-May-2021 does not contain any new information. On 19-May-2021: Treatment medications for the event added. On 25-May-2021: Outcome of event changed to recovering/resolving.

Other Meds:

Current Illness:

ID: 1609269
Sex: F
Age: 74
State:

Vax Date: 04/09/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: injection arm soreness; diarrhea; fever on and off; chills on and off; nausea; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (injection arm soreness), DIARRHOEA (diarrhea), PYREXIA (fever on and off), CHILLS (chills on and off) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical History was Provided by Reporter. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection arm soreness), DIARRHOEA (diarrhea), PYREXIA (fever on and off), CHILLS (chills on and off) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection arm soreness), DIARRHOEA (diarrhea), PYREXIA (fever on and off), CHILLS (chills on and off) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were provided are High Blood pressure Medication, Coumadin, Medication for Acid Reflux. Treatment medications were provided are Tylenol and Imodium.

Other Meds: COUMADIN

Current Illness:

ID: 1609270
Sex: F
Age: 86
State: MD

Vax Date: 03/26/2021
Onset Date: 03/29/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: shortness of breath; weak cold; not getting the 2nd vaccine; Still not feeling well; shivering; fatigue; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), DYSPNOEA (shortness of breath ), FEELING COLD (weak cold) and PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Autoimmune disorder and Graves' disease. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and NIFEDIPINE for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ASTHENIA (weakness) and DIZZINESS (dizziness). On an unknown date, the patient experienced DYSPNOEA (shortness of breath ), FEELING COLD (weak cold), PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine), MALAISE (Still not feeling well), CHILLS (shivering) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), DYSPNOEA (shortness of breath ), FEELING COLD (weak cold), PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine), MALAISE (Still not feeling well), CHILLS (shivering) and FATIGUE (fatigue) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided/unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-080292 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: New AE's and other relevant history was added; Sender's Comments: US-MODERNATX, INC.-MOD-2021-080292:son case

Other Meds: CRESTOR; NIFEDIPINE

Current Illness: Autoimmune disorder; Graves' disease

ID: 1609271
Sex: M
Age:
State: FL

Vax Date: 03/19/2021
Onset Date: 04/17/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: slept all day; no memory at all/He does not remember anything from the whole day/completely lost; Cold/spent the whole day in bed under the covers because he was cold; he does not remember getting up on Saturday until about 11:30pm at night; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (no memory at all/He does not remember anything from the whole day/completely lost), FEELING COLD (Cold/spent the whole day in bed under the covers because he was cold), BEDRIDDEN (he does not remember getting up on Saturday until about 11:30pm at night) and SOMNOLENCE (slept all day) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 030A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included METFORMIN, LEVOTHYROXINE, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced AMNESIA (no memory at all/He does not remember anything from the whole day/completely lost), FEELING COLD (Cold/spent the whole day in bed under the covers because he was cold) and BEDRIDDEN (he does not remember getting up on Saturday until about 11:30pm at night). On an unknown date, the patient experienced SOMNOLENCE (slept all day). At the time of the report, AMNESIA (no memory at all/He does not remember anything from the whole day/completely lost), FEELING COLD (Cold/spent the whole day in bed under the covers because he was cold), BEDRIDDEN (he does not remember getting up on Saturday until about 11:30pm at night) and SOMNOLENCE (slept all day) outcome was unknown. No treatment information was provided. Patient is overweight. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-080485 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-080485:Dose 1

Other Meds: METFORMIN; LEVOTHYROXINE; LOSARTAN; HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1609272
Sex: M
Age: 56
State: NY

Vax Date: 03/28/2021
Onset Date: 04/09/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Instructed not to get the second dose; COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) and INTENTIONAL DOSE OMISSION (Instructed not to get the second dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Instructed not to get the second dose). At the time of the report, COVID-19 (COVID-19) outcome was unknown and INTENTIONAL DOSE OMISSION (Instructed not to get the second dose) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date. Concomitant product use was not provided by the reporter. Treatment information included antibody treatment on 13 Apr 2021 due to which the patient was advised not to receive the second dose for 90 days from the treatment.

Other Meds:

Current Illness:

ID: 1609273
Sex: F
Age: 80
State: FL

Vax Date: 03/13/2021
Onset Date: 04/11/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: chills; headache; extreme nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (extreme nausea) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced CHILLS (chills), HEADACHE (headache), NAUSEA (extreme nausea) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), HEADACHE (headache), NAUSEA (extreme nausea) and FATIGUE (fatigue) had not resolved. Not Provided No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not Applicable.

Other Meds:

Current Illness:

ID: 1609274
Sex: F
Age: 66
State: PA

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Difficulty breathing; Diarrhea; Swelling under tooth line on soft tissue; May have been a blocked salivary duct or swollen lymph nodes; Latest swelling she experienced hit her like a brick; Second dose not received; Chills; Nausea; Difficulty swallowing; Dizziness; Neck and clavicle swelling/concerned about the Carotid artery due to swelling in that area; Irregular heart rate/palpitations; Chest tightness; Fatigue; Vaccination site pain; Headache; Facial and jaw swelling & face swelling on the base of her neck again near the carotid artery/facial swelling began on left side of face and neck; Pain in her face; Sore throat; Fever/temp fluctuated between 98.6 and 100.9; Sore arm; Got very cold; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), FACIAL PAIN (Pain in her face), SWELLING FACE (Facial and jaw swelling & face swelling on the base of her neck again near the carotid artery/facial swelling began on left side of face and neck), DYSPHAGIA (Difficulty swallowing) and DIZZINESS (Dizziness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Numbness in fingers, Pneumonia, Headache and Root canal procedure. Previously administered products included for Influenza immunisation: Flu shot (The patient described flu-like symptoms and reported that patient was chronically ill with colds, several bouts of bronchitis, one bout of pneumonia for a total of 9 months and never had another flu shot until approx. 15 years later. My allergist gave it in 3 doses, then for several years two doses, then 1 dose, then back to 2 doses. Reactions were numbness and tingling in fingers and arm, severe headaches. I must pre and post medicate with one dose Zyrtec 2 days prior, the day of the shot with Zyrtec in the AM and in the PM plus Tylenol ? hr. prior to the shot and then 1 dose Zyrtec the following two days.) in October 2011; for Hypothyroidism: Armor thyroid (For 6-8 years) and Synthroid (For 12 years). Past adverse reactions to the above products included Flu like symptoms with Flu shot; No adverse event with Armor thyroid; and No adverse reaction with Synthroid. Concurrent medical conditions included Pollen allergy, Allergy to vaccine (Flu-like symptoms) since October 2011, Drug allergy (My first root canal I had many doses of Novocain which didn't numb me totally. Afterward I had facial swelling on the left side of my face which came and went spontaneously, often completely closing my left eye. It lasted approx. 1 month.), Contrast media allergy (Red Rash all over), Drug allergy (Dark thoughts), Shellfish allergy (Allergic to Bivalve shellfish. Caused Diarrhea), Drug allergy (Allergic to Lisinopril), Drug allergy (Allergic to Zofran Anaphylaxis reaction), Allergy to antibiotic (Allergic to Erythromycin), Drug allergy (Allergic to Celexa), Drug allergy (Allergic to Prednisone. Caused Rash), Drug allergy (Allergic to Advair. Caused Itchy rash), Allergy to antibiotic (Allergic to Augmentin-Diarrhea), Milk allergy (From age 7. Hives in mouth; lactose intolerant since my 40s. This includes milk in liquid form or soft cheeses only: i.e. milk, milk shakes, ice cream, cottage cheese, pudding etc.), Hereditary leiomyomatosis renal cell carcinoma, Irritable bowel syndrome, Hypothyroidism, Cataract, Adhesive tape allergy (Allergy to Bandage adhesive. Caused Blisters), Allergy to antibiotic (Allergic to Antibiotic cream. Caused Blisters and rash) and Contrast media allergy (Allergic to MRI Contrast. Caused Anaphylaxis). Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) for Hypothyroidism, VITAMIN D3, MULTIVITAMIN [VITAMINS NOS], BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and PARACETAMOL (TYLENOL) for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FEELING COLD (Got very cold). On 18-Feb-2021, the patient experienced MYALGIA (Sore arm). On 16-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever/temp fluctuated between 98.6 and 100.9). On 26-Mar-2021, the patient experienced FACIAL PAIN (Pain in her face). On 08-Apr-2021, the patient experienced SWELLING FACE (Facial and jaw swelling & face swelling on the base of her neck again near the carotid artery/facial swelling began on left side of face and neck). On an unknown date, the patient experienced DYSPHAGIA (Difficulty swallowing), DIZZINESS (Dizziness), SWELLING (Neck and clavicle swelling/concerned about the Carotid artery due to swelling in that area), PALPITATIONS (Irregular heart rate/palpitations), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), GINGIVAL SWELLING (Swelling under tooth line on soft tissue), LYMPHADENOPATHY (May have been a blocked salivary duct or swollen lymph nodes), FEELING ABNORMAL (Latest swelling she experienced hit her like a brick), PRODUCT DOSE OMISSION ISSUE (Second dose not received), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), VACCINATION SITE PAIN (Vaccination site pain) and HEADACHE (Headache). The patient was treated with CLINDAMYCIN for Swelling, at a dose of 300 mg and IBUPROFEN (ADVILMED) at a dose of 1 dosage form. On 23-May-2021, PYREXIA (Fever/temp fluctuated between 98.6 and 100.9) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), FACIAL PAIN (Pain in her face), SWELLING FACE (Facial and jaw swelling & face swelling on the base of her neck again near the carotid artery/facial swelling began on left side of face and neck), DYSPHAGIA (Difficulty swallowing), DIZZINESS (Dizziness), SWELLING (Neck and clavicle swelling/concerned about the Carotid artery due to swelling in that area), PALPITATIONS (Irregular heart rate/palpitations), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), GINGIVAL SWELLING (Swelling under tooth line on soft tissue), LYMPHADENOPATHY (May have been a blocked salivary duct or swollen lymph nodes), FEELING ABNORMAL (Latest swelling she experienced hit her like a brick), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Sore arm) and HEADACHE (Headache) had not resolved, FEELING COLD (Got very cold) had resolved and PRODUCT DOSE OMISSION ISSUE (Second dose not received), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: negative (Negative) negative. On 30-Mar-2021, Computerised tomogram: negative (Negative) negative. On 30-Mar-2021, X-ray: abnormal (abnormal) definite swelling. Nasal passages were clear.. On 21-Apr-2021, Laryngoscopy: normal (normal) normal Nasal passages throat and vocal cords were fine. Liquid from salivary glands clear. On an unknown date, Body temperature: 98.6 - 100.9 (abnormal) 98.6 - 100.9. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient visited Dentist, EENT, endodontist, and physician to rule out the blocked salivary duct, swelling in face neck and clavicular area and was also concerned about the carotid artery. Due to swelling in that area patient had difficulty in breathing, swallowing, and choking at times. Patient also visited their ophthalmologist because swelling has affected their eyes and for their cataract surgery which was postponed for two months because of swelling. The patient also reported that before receiving any vaccine they took medication to overcome its effects but in case of mRNA1273 they did not take any medication prior to shot. On 21-July-2021, the patient reported that 5 months after the first vaccine, the patient still experiencing the side effect and reported that they consulted with an EENT specialist who did a scope of their nasal passages and vocal cords and the result w

Other Meds: TIROSINT; VITAMIN D3; MULTIVITAMIN [VITAMINS NOS]; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; ZYRTEC ALLERGY; TYLENOL

Current Illness: Adhesive tape allergy (Allergy to Bandage adhesive. Caused Blisters); Allergy to antibiotic (Allergic to Erythromycin); Allergy to antibiotic (Allergic to Augmentin-Diarrhea); Allergy to antibiotic (Allergic to Antibiotic cream. Caused Blisters and rash); Allergy to vaccine (Flu-like symptoms); Cataract; Contrast media allergy (Red Rash all over); Contrast media allergy (Allergic to MRI Contrast. Caused Anaphylaxis); Drug allergy (My first root canal I had many doses of Novocain which didn't numb me totally. Afterward I had facial swelling on the left side of my face which came and went spontaneously, often completely closing my left eye. It lasted approx. 1 month.); Drug allergy (Dark thoughts); Drug allergy (Allergic to Zofran Anaphylaxis reaction); Drug allergy (Allergic to Prednisone. Caused Rash); Drug allergy (Allergic to Lisinopril); Drug allergy (Allergic to Celexa); Drug allergy (Allergic to Advair. Caused Itchy rash); Hereditary leiomyomatosis renal cell carcinoma; Hypothyroidism; Irritable bowel syndrome; Milk allergy (From age 7. Hives in mouth; lactose intolerant since my 40s. This includes milk in liquid form or soft cheeses only: i.e. milk, milk shakes, ice cream, cottage cheese, pudding etc.); Pollen allergy; Shellfish allergy (Allergic to Bivalve shellfish. Caused Diarrhea)

ID: 1609275
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Red knot at the site of injection; Red knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Red knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection). At the time of the report, VACCINATION SITE MASS (Red knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and treatment information were not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1609276
Sex: F
Age: 68
State: CA

Vax Date: 02/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: blood pressure; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and BLOOD PRESSURE MEASUREMENT (blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A219 and 15M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced BLOOD PRESSURE MEASUREMENT (blood pressure). On 12-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, BLOOD PRESSURE MEASUREMENT (blood pressure) was resolving. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 144/?, 140/? (High) 144/?, 140/?. On 18-Apr-2021, Blood pressure measurement: 145/85 (High) 145/85. On 19-Apr-2021, Blood pressure measurement: 123/77, 128/69 (High) 123/77, 128/69. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-080489 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added additional event; Sender's Comments: MOD-2021-080489:Dose-1

Other Meds: AMLODIPINE

Current Illness: Blood pressure high

ID: 1609277
Sex: M
Age: 54
State: NJ

Vax Date: 03/27/2021
Onset Date: 04/03/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Positive for Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for Covid-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (Positive for Covid-19). The patient was treated with Immunotherapy (MONOCLONAL ANTIBIOTICS) for COVID-19. At the time of the report, COVID-19 (Positive for Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. The patient received treatment on 05 Apr 2021.

Other Meds:

Current Illness:

ID: 1609278
Sex: F
Age: 44
State: IN

Vax Date: 04/15/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: period came on 2 weeks early and very heavy; period came on 2 weeks early and very heavy; patient is crying a lot; moody; anxious; nervous; sad; Pain; chills; low grade fever; muscle aches; nauseous; This spontaneous case was reported by a patient and describes the occurrence of MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody) and ANXIETY (anxious) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody), ANXIETY (anxious), NERVOUSNESS (nervous), DEPRESSED MOOD (sad), PAIN (Pain), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (muscle aches) and NAUSEA (nauseous). At the time of the report, MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody), ANXIETY (anxious), NERVOUSNESS (nervous), DEPRESSED MOOD (sad), PAIN (Pain), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (muscle aches) and NAUSEA (nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and treatment information were not provided.

Other Meds:

Current Illness:

ID: 1609279
Sex: M
Age:
State: OK

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Hives on different part of his body; Pimple bumps; Very itchy; Sore arm; Rashes on different part of his body, rash on scalps; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on different part of his body), ACNE (Pimple bumps), RASH PRURITIC (Very itchy), PAIN IN EXTREMITY (Sore arm) and RASH (Rashes on different part of his body, rash on scalps) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 025A20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives on different part of his body), ACNE (Pimple bumps), RASH PRURITIC (Very itchy), PAIN IN EXTREMITY (Sore arm) and RASH (Rashes on different part of his body, rash on scalps). At the time of the report, URTICARIA (Hives on different part of his body), ACNE (Pimple bumps), RASH PRURITIC (Very itchy) and RASH (Rashes on different part of his body, rash on scalps) outcome was unknown and PAIN IN EXTREMITY (Sore arm) had resolved. Action taken with mRNA-1273 in response to the events was not Applicable. Patient experienced sore arm after the shot which subsided after some days. Few weeks after getting the second shot he started having hives, rashes and pimple bumps at different parts of his body including his scalps. The rashes were off and on, they were also very itchy. He called his cardiologist because he thought it was his heart medications that was causing the symptoms. He was planning to call his primary healthcare provider. Patient had issues with is hearing aid, his helped with some of the information. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1609280
Sex: M
Age: 67
State: IN

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Loss of appetite; low grade fever; Chills; Nausea; Muscle pain; Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (COVID- 19 positive.) in November 2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and OMEPRAZOLE for an unknown indication. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (Pounding headache). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and HEADACHE (Pounding headache) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds: LIPITOR; OMEPRAZOLE

Current Illness:

ID: 1609281
Sex: F
Age:
State: CA

Vax Date: 04/09/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Allergy (many types of unspecified allergies)

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pruritus (itching on left arm), vaccination site erythema (red rash spreading 4-5 inches down the arm) and vaccination site rash (red rash spreading 4-5 inches down the arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included many types of unspecified allergies. On Apr 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 16, 2021, patient experienced vaccination site pruritus (itching on left arm), vaccination site erythema (red rash spreading 4-5 inches down the arm) and vaccination site rash (red rash spreading 4-5 inches down the arm). At the time of the report, vaccination site pruritus (itching on left arm), vaccination site erythema (red rash spreading 4-5 inches down the arm) and vaccination site rash (red rash spreading 4-5 inches down the arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported. Treatment included, a disinfectant, organic apple cider vinegar and hydrogen peroxide.

Other Meds:

Current Illness: Allergy (many types of unspecified allergies)

ID: 1609282
Sex: F
Age: 73
State: PA

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: ?little bruising on right arm after the 2nd shot ?; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (?little bruising on right arm after the 2nd shot ?) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (?little bruising on right arm after the 2nd shot ?). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of one hour before the 1st and the 2nd Moderna shot. At the time of the report, VACCINATION SITE BRUISING (?little bruising on right arm after the 2nd shot ?) outcome was unknown. Not Provided Other concomitant medications were reported included Lupus Medication,Blood pressure medication,medicine for depression and cholesterol medicine. This case was linked to US-MODERNATX, INC.-MOD-2021-080362 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non Significant:Contact information updated. On 19-Jul-2021: Follow up information received and contains non significant information- Husbands Information provided; Sender's Comments: US-MODERNATX, INC.-MOD-2021-080362:Husband case

Other Meds: BABY ASPIRIN

Current Illness:

ID: 1609283
Sex: M
Age:
State: CA

Vax Date: 04/16/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: fever; was tired for a couple of days; heartbeat was unbelievably fast; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heartbeat was unbelievably fast), PYREXIA (fever) and FATIGUE (was tired for a couple of days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PALPITATIONS (heartbeat was unbelievably fast). On an unknown date, the patient experienced PYREXIA (fever) and FATIGUE (was tired for a couple of days). The patient was treated with PARACETAMOL (TYLENOL) on 16-Apr-2021 at a dose of 1 dosage form. At the time of the report, PALPITATIONS (heartbeat was unbelievably fast), PYREXIA (fever) and FATIGUE (was tired for a couple of days) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1609284
Sex: F
Age: 67
State: MN

Vax Date: 02/26/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: fell a couple of times; wanted to sleep all day; Super sick; felt strange, terrible; felt dizzy; like throwing up; felt like throwing up; Second shot was given more than 36 days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible) and DIZZINESS (felt dizzy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0101A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (She was diagnosed with Co-vid 19 back in Mar2020) in March 2020 and Back surgery. Concomitant products included OXYCODONE for Pain, COLECALCIFEROL (VIT D3), CALCIUM and TIZANIDINE for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced OFF LABEL USE (Second shot was given more than 36 days after first shot). On 17-Apr-2021, the patient experienced FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible), DIZZINESS (felt dizzy), NAUSEA (like throwing up) and VOMITING (felt like throwing up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Apr-2021, OFF LABEL USE (Second shot was given more than 36 days after first shot) had resolved. At the time of the report, FALL (fell a couple of times), SOMNOLENCE (wanted to sleep all day), ILLNESS (Super sick), FEELING ABNORMAL (felt strange, terrible), DIZZINESS (felt dizzy), NAUSEA (like throwing up) and VOMITING (felt like throwing up) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. This case was linked to MOD21-078174 (Patient Link).

Other Meds: VIT D3; CALCIUM; TIZANIDINE; OXYCODONE.

Current Illness:

ID: 1609285
Sex: M
Age:
State: NC

Vax Date: 04/12/2021
Onset Date: 04/18/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Swollen lymph node on the neck,about the size of a dime; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node on the neck,about the size of a dime) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swollen lymph node on the neck,about the size of a dime). At the time of the report, LYMPHADENOPATHY (Swollen lymph node on the neck,about the size of a dime) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1609286
Sex: F
Age: 22
State: FL

Vax Date: 03/19/2021
Onset Date: 03/18/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: body aches; arm stiffness & shoulder stiffness; tenderness; warm neck; swollen neck; severe arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck) and SWELLING (swollen neck) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck), SWELLING (swollen neck) and PAIN IN EXTREMITY (severe arm soreness). On 19-Mar-2021, MYALGIA (body aches), MUSCULOSKELETAL STIFFNESS (arm stiffness & shoulder stiffness), TENDERNESS (tenderness), FEELING HOT (warm neck), SWELLING (swollen neck) and PAIN IN EXTREMITY (severe arm soreness) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment medications were provided No Concomitant medications were provided This case was linked to US-MODERNATX, INC.-MOD-2021-080626 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-080626:2nd dose case

Other Meds:

Current Illness:

ID: 1609287
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: side effects after first and second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects after first and second dose of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects after first and second dose of vaccine). At the time of the report, ADVERSE DRUG REACTION (side effects after first and second dose of vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication and treatment details were provided. This case was linked to US-MODERNATX, INC.-MOD-2021-080584 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-080584:

Other Meds:

Current Illness:

ID: 1609288
Sex: M
Age:
State: AZ

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. Concomitant product use was not provided by the reported.

Other Meds:

Current Illness:

ID: 1609289
Sex: F
Age: 88
State: IL

Vax Date: 10/20/2020
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: diarrhea recurrent; erythema of extremities; swelling arm; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (diarrhea recurrent), ERYTHEMA (erythema of extremities) and PERIPHERAL SWELLING (swelling arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication. No Medical History information was reported. On 20-Oct-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea recurrent), ERYTHEMA (erythema of extremities) and PERIPHERAL SWELLING (swelling arm). At the time of the report, DIARRHOEA (diarrhea recurrent), ERYTHEMA (erythema of extremities) and PERIPHERAL SWELLING (swelling arm) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am